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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.
The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa 2a+Ribavirin | No Intervention | standard of care for HCV : peginterferon alfa 2a and ribavirin | |
| Vit D+Peginterferon alfa 2a+Ribavirin | Experimental | VitD+Peginterferon alfa 2a+Ribavirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vit D | Drug | 800IU/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Sustained virologic response (SVR) | Compare the number of participants with HCV RNA is not detected in the blood at 24 weeks post-treatment between vitamin D and control group. | 24w after completing Peg/RBV |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with End of treatment response (ETR) | Compare the number of participants with HCV RNA is not detected in the blood at the end of treatment between two groups. HCV RNA pCR perform at 48 weeks in genotye 1, at 24 weeks in Genotye 2 and 3 | 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang university Hospital Cheonan | Cheonan | Chungcheongnam-do | 330721 | South Korea | ||
| Soonchunhyang university hospital Bucheon |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D
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Vitamin D add
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| Number of participants with Rapid virological response (RVR) |
Compare the number of participants with HCV RNA is notdetectable in the blood at week 4 of treatment between vitamin and control group |
| Week 4 |
| Number of participants with Early virological response (EVR) | Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group | Week 12 |
| Bucheon-si |
| Gyeonggi-do |
| 420767 |
| South Korea |
| HANYANG University Guri Hospital | Guri-si | Gyeonggido | 471701 | South Korea |
| Bundang Jesaeng Hospital | Seongnam | Gyeonggido | 463774 | South Korea |
| Chuncheon Sacred Heart Hospital | Chuncheon | Kangwondo | 200704 | South Korea |
| Wonju Christian Hospital | Wŏnju | Kangwondo | 220-701 | South Korea |
| Kyong Hee University Medical Center | Seoul | 130702 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 133792 | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | 134701 | South Korea |
| Gangnam Severance Hospital | Seoul | 135720 | South Korea |
| Sooncunhayng University Hospital Seoul | Seoul | 140887 | South Korea |
| BORAMAE Medical Center | Seoul | 156707 | South Korea |
| Chungang University Hospital | Seoul | 156861 | South Korea |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |